Range and Consistency of Infection Outcomes Reported in Trials Conducted in Kidney Transplant Recipients: A Systematic Review

Samuel Chan^{1

2

3}, Eric Au^{4

5}, David W Johnson^{1

2

3}, Carmel M Hawley^{1

2

3}, Allison Tong^{4

5}, Elaine M Pascoe^{1

2}, Jonathan C Craig⁶, Benedicte Sautenet^{5

7}, Emily A Blumberg⁸, Daniel Brennan⁹, Scott B Campbell^{1

2

3}, Christopher Cao¹, Ross S Francis^{1

2}, Brooke Huuskes¹⁰, Nicole M Isbel^{1

2}, Greg Knoll¹¹, Camille N Kotton¹², Nizam Mamode¹³, Elmi Muller¹⁴, Hai An Ha Phan¹⁵, Helio Tedesco-Silva¹⁶, David M White¹⁷, Martin J Wolley^{2

18}, Andrea K Viecelli^{1

2

3}

Affiliations

¹ Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia.
² Faculty of Medicine, The University of Queensland, Brisbane, QLD, Australia.
³ Translational Research Institute, Brisbane, QLD, Australia.
⁴ Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
⁵ Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, Australia.
⁶ College of Medicine and Public Health, Flinders University, SA, Australia.
⁷ Service de Nephrologie-Hypertension, Dialyses, Transplantation Rénale, Hopital Bretonneau, Université de Tours, Université de Nantes, INSERM SPHERE U 1246, Tours, France.
⁸ Division of Infectious Diseases, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
⁹ Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, MD.
¹⁰ Department of Physiology, Anatomy and Microbiology, School of Life Sciences, La Trobe University, Melbourne, VIC, Australia.
¹¹ Division of Nephrology, Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
¹² Transplant and Immunocompromised Host Infectious Diseases Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
¹³ Department of Transplantation, Guy's and St Thomas' NHS Foundation Trust, London, England, United Kingdom.
¹⁴ Department of Surgery, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.
¹⁵ Kidney Diseases and Dialysis Department, Viet Duc University Hospital, Vietnam.
¹⁶ Division of Nephrology, Hospital do Rim, Universidade Federal de Sao Paulo, Sao Paulo, Brazil.
¹⁷ Dreyfus Health Policy and Research Center, Brooklyn, NY.
¹⁸ Kidney Health Service, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.

PMID: 33653998
DOI: 10.1097/TP.0000000000003723

Range and Consistency of Infection Outcomes Reported in Trials Conducted in Kidney Transplant Recipients: A Systematic Review

Samuel Chan et al. Transplantation. 2021.

. 2021 Dec 1;105(12):2632-2638.

doi: 10.1097/TP.0000000000003723.

Authors

Affiliations

¹ Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia.
² Faculty of Medicine, The University of Queensland, Brisbane, QLD, Australia.
³ Translational Research Institute, Brisbane, QLD, Australia.
⁴ Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
⁵ Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, Australia.
⁶ College of Medicine and Public Health, Flinders University, SA, Australia.
⁷ Service de Nephrologie-Hypertension, Dialyses, Transplantation Rénale, Hopital Bretonneau, Université de Tours, Université de Nantes, INSERM SPHERE U 1246, Tours, France.
⁸ Division of Infectious Diseases, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
⁹ Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, MD.
¹⁰ Department of Physiology, Anatomy and Microbiology, School of Life Sciences, La Trobe University, Melbourne, VIC, Australia.
¹¹ Division of Nephrology, Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
¹² Transplant and Immunocompromised Host Infectious Diseases Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
¹³ Department of Transplantation, Guy's and St Thomas' NHS Foundation Trust, London, England, United Kingdom.
¹⁴ Department of Surgery, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.
¹⁵ Kidney Diseases and Dialysis Department, Viet Duc University Hospital, Vietnam.
¹⁶ Division of Nephrology, Hospital do Rim, Universidade Federal de Sao Paulo, Sao Paulo, Brazil.
¹⁷ Dreyfus Health Policy and Research Center, Brooklyn, NY.
¹⁸ Kidney Health Service, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.

PMID: 33653998
DOI: 10.1097/TP.0000000000003723

Abstract

Background: Infection remains a leading cause of death in kidney transplant recipients. This study aimed to assess the scope and consistency of infection outcomes reported in contemporary trials conducted in kidney transplant recipients.

Methods: A literature review of all randomized trials and trial protocols reporting infection outcomes in adult kidney transplant recipients was identified in the Cochrane Kidney and Transplant Specialized Register from January 2014 to July 2019. Characteristics and infection outcomes from the trials were analyzed.

Results: From 102 included trials, 772 outcome measures were extracted and categorized into 216 unique measures with a median of 3.2 outcome measures per trial (range: 1-9). Measures were further grouped into 32 outcomes based on site of infection (14 outcomes) and organism (18 outcomes). The most commonly reported site-specific outcome and organism-specific outcome were systemic infection (71% trials) and cytomegalovirus infection (62% trials), respectively. Outcome metric and methods of aggregation included mean, median, proportion, proportional change, and number of patients with at least 1 episode. Across all trials, measures were assessed at 55 different time points with a range of 1-11 time points per trial.

Conclusions: Infection outcomes in kidney transplant recipients were frequently reported by site and organism but varied widely in terms of outcome, metrics, method of aggregation, and time point of measurement. Establishment of core outcomes for infection based on the shared priorities of patients/caregivers and health professionals may improve the consistency, comparability, and usefulness of trial evidence.

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Conflict of interest statement

S.C. is supported by the Australian National Health and Medical Research Council (NHMRC) Postgraduate Scholarship, the Microba recipient grant, the Metro South Research Support Scheme, and the Royal Australasian College of Physicians (RACP) Jacquot NHMRC Research Excellence top-up award. E.A. is supported by a NHMRC Postgraduate Scholarship and RACP Jacquot NHMRC Award for Excellence. C.M.H. is the recipient of research grants paid to her institution from Baxter Healthcare and Fresenius Medical Care and from Otsuka, Janssen, and GlaxoSmithKline for trial steering committee activities, paid to her institution. D.W.J. has received consultancy fees, research grants, speaker’s honoraria, and travel sponsorships from Baxter Healthcare and Fresenius Medical Care. He has received consultancy fees from Astra Zeneca and AWAK, speaker’s honoraria from Ono, and travel sponsorships from Amgen. He is a current recipient of an Australian NHMRC Practitioner Fellowship. N.M.I. has received consultancy fees and speakers honoraria from Alexion Pharmaceuticals, Novo Nordisk, and Amgen. A.T. is supported by the NHMRC Research Fellowship. A.K.V. receives grant support from the Royal Australasian College of Physicians (Jacquot Research Establishment Award) and the Princess Alexandra Research Foundation. D.B. receives institutional research grant funding from CareDx, speaking honoraria from CareDx and Veloxis and is a consultant for AlloVir, Amplyx, Argenyx, CareDx, Medeor, Natera, Sanofi, and Veloxis. D.B. is supported by NIDDK U01 DK116042-01 and R01DK102981. The other authors declare no conflicts of interest.

Comment in

The Challenge of Infection Outcomes in Clinical Trials.
Avery R. Avery R. Transplantation. 2021 Dec 1;105(12):2522-2523. doi: 10.1097/TP.0000000000003724. Transplantation. 2021. PMID: 33653999 No abstract available.

References

1. Fishman JA. Infection in organ transplantation. Am J Transplant. 2017;17:856–879.
1. Chan S, Pascoe EM, Clayton PA, et al. Infection-Related Mortality in Recipients of a Kidney Transplant in Australia and New Zealand. Clin J Am Soc Nephrol. 2019;14:1484–1492.
1. Sousa SRd, Galante NZ, Barbosa DA, et al. Incidência e fatores de risco para complicações infecciosas no primeiro ano após o transplante renal. J Bras Nefrol. 2010;32:77–84.
1. Kumar MS, Cridge P, Molavi A, et al. Infectious complications in the first 100 days after renal transplantation. Transplant Proc. 1995;27:2705–2706.
1. Alangaden GJ, Thyagarajan R, Gruber SA, et al. Infectious complications after kidney transplantation: current epidemiology and associated risk factors. Clin Transplant. 2006;20:401–409.

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Range and Consistency of Infection Outcomes Reported in Trials Conducted in Kidney Transplant Recipients: A Systematic Review

Affiliations

Range and Consistency of Infection Outcomes Reported in Trials Conducted in Kidney Transplant Recipients: A Systematic Review

Authors

Affiliations

Abstract

Conflict of interest statement

Comment in

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical